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Impact of bone graft and membrane on maintaining alveolar bone structure in diabetic patients after tooth extraction

Efficacy of Alveolar Ridge Preservation with Xenograft Combined with Collagen Membrane in Diabetic Patients: a randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-52rrmwg
Enrollment
Unknown
Registered
2025-01-14
Start date
2024-10-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alveolar Bone Grafting

Interventions

This is a parallel two-arm randomized controlled clinical trial. Using a random allocation table generated in Microsoft Excel, the post-extraction sockets will be randomly assigned to two experimental
only the evaluator responsible for assessing clinical and imaging outcomes will remain blinded
E06.892

Sponsors

Universidade de São Paulo
Lead Sponsor
Bioinovação Biomédica Limitada
Collaborator

Eligibility

Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: The study will include participants of both genders; aged between 18 and 70 years; who have been diagnosed with type II diabetes mellitus and present HbA1c levels between 6% and 10% (ASA II); must need the extraction of upper dental elements (excluding molars) and lower dental elements (excluding molars and incisors); performed using the closed technique; have no active periapical and/or periodontal infection

Exclusion criteria

Exclusion criteria: Individuals with other metabolic diseases that negatively impact bone metabolism, such as osteoporosis and hyperparathyroidism; participants who fail to attend follow-up appointments or those whose extraction procedures require bone tissue removal (osteotomy); experience any intraoperative complications, such as root fracture, bone fracture, loss of alveolar integrity, or hemorrhage, will be excluded from the study

Design outcomes

Primary

MeasureTime frame
Thickness of the alveolar bone crest after alveolar ridge preservation in patients with type 2 diabetes mellitus

Secondary

MeasureTime frame
Height and width of the alveolar bone tissue; height and width of the soft tissue; wound healing; postoperative pain; complications; and patient experience

Countries

Brazil

Contacts

Public ContactEmanuela Ferraz

Universidade de São Paulo

emanuelaferraz@usp.br+55(16)33154018

Outcome results

None listed

Source: REBEC (via WHO ICTRP)